Prepackaged pharmaceutical solutions are used to deliver intravenous solutions and medicines to patients for a variety of medical disorders. These solutions are commonly commercially prepared by heat sterilization methods. Often the prepared solutions will not be used immediately, thus necessitating the alteration of the pH to insure chemical stability. Prepackaged pharmaceuticals may also require preservative additives (anti-oxidants) to help preserve freshness. Glucose solutions, for example, are unstable if kept at a neutral or basic pH for long periods of time.
A problem seen with heat sterilized dextrose solutions is the formation of caramelization products of the glucose, unless the pH of the dextrose is in the range of 3-5. Acidic breakdown products, such as glycuronic acids and 5-hydroxymethylfuraldehyde, also lower the pH of the solution. Administration of solutions with the lowered pH leads to cases of post-infusion thrombophlebites. Where a buffering agent, such as sodium bicarbonate, is added to raise the pH to near physiological levels, the incidence of post infusion phlebites is decreased.
The physiological pH will vary depending on the body fluid the pharmaceutical solution is entering. For example, the arterial blood PH range is 7.38-7.44. The cerebro-spinal fluid pH range is 7.14-7.50.
Pharmaceutical solutions may need to be isotonic to prevent the net transfer of water across a membrane. Isotonicity is very important in the preparation of opthalmic pharmaceuticals. It is also known that acidic hypertonic solutions of dextrose in water are likely to cause phlebitis.
A device and method for the rapid preparation of fresh pharmaceutical solutions of known composition made from medicinal ingredients is disclosed in U.S. Pat. No. 4,906,103, incorporated by reference herein. This device includes a first bag with attached containers, a second bag, a filtration unit and a means of exerting positive pressure on the first bag. Medicinal ingredients are located in containers attached to the walls of the first bag of the device. The pharmaceutical solution is produced by adding sterile nonpyrogenic water or other suitable U.S.P. solution to the unit, snapping off the container tops from containers containing the medical ingredients needed for the medical disorder, and forcing the solution through a connected filtration unit into a second bag of the device. This apparatus advantageously allows the provision of sterile liquids prepared immediately prior to infusion and filtered rapidly enough to avoid formation of pyrogens. This apparatus includes medicinal ingredient containers fixed to the side walls of the bags which contain different ingredients suited for treatment of a variety of conditions.
It is particularly important when preparing medical solutions of precise concentrations that the containers be fully emptied into the sterile liquids and completely mixed. In harsh conditions present in poorly lit and equipped hospitals, emergency applications in the field, or in high-stress military situations, it is important that the medicinal containers be readily identifiable and easily emptied.
What is needed is a device for preparing solutions for certain medical applications which has medicinal ingredient holders which are easily and rapidly identifiable to insure that the proper medical ingredient is added to the sterile U.S.P. solution, with provision for quickly and effectively emptying the medical ingredients into the sterile U.S.P. solution.